PHARMULATOR

FDA 510(k)

FDA Class 2 ·General Hospital

DOCUMENT R AMMONIA/ETHANOL CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE, TWO PASTE BONDING SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

PRESS-FIT HEAD RESURFACING DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

DIFCO DIRECTOR INOCULATION SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

MAEDA SILVER ACUPUNCTURE NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

BILE ACIDS CONTROLS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ELECTONE BTE MODEL AM900 PP

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

ZIRCONIA CERAMIC MODULAR HEAD 9TYPE II TAPER

FDA 510(k)

FDA Class 2 ·Orthopedic

SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS)

FDA 510(k)

FDA Class 2 ·Orthopedic

SCEPTOR STREPTOCOCCUS MIC PANEL #80322

FDA 510(k)

FDA Class 2 ·Microbiology

EMIT II PLUS ECSTASY ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VSA 3000 VIBRATORYN SENSORY ANALYZER

FDA 510(k)

FDA Class 1 ·Neurology

DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INDXTM DIP-S-TICKSTM

FDA 510(k)

FDA Class 1 ·Microbiology

STERRAD CHEMICAL INDICATOR

FDA 510(k)

FDA Class 2 ·General Hospital

PLANET MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL

FDA 510(k)

FDA Class 2 ·Radiology